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FDA 510(k) Application Details - K031773
Device Classification Name
Endoscopic Irrigation/Suction System
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510(K) Number
K031773
Device Name
Endoscopic Irrigation/Suction System
Applicant
BYRNE MEDICAL, INC.
11874 SOUTH EVELYN CIRCLE
HOUSTON, TX 77071 US
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Contact
J. HARVEY KNAUSS
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Regulation Number
876.1500
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Classification Product Code
OCX
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More FDA Info for this Product Code
Date Received
06/09/2003
Decision Date
06/24/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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